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EP2306817A1 - Zusammensetzungen zur behandlung von tierläusen - Google Patents

Zusammensetzungen zur behandlung von tierläusen

Info

Publication number
EP2306817A1
EP2306817A1 EP09794097A EP09794097A EP2306817A1 EP 2306817 A1 EP2306817 A1 EP 2306817A1 EP 09794097 A EP09794097 A EP 09794097A EP 09794097 A EP09794097 A EP 09794097A EP 2306817 A1 EP2306817 A1 EP 2306817A1
Authority
EP
European Patent Office
Prior art keywords
oil
hair
hair care
seed
formulation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP09794097A
Other languages
English (en)
French (fr)
Inventor
Ahron Chazot
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lice Up Ltd
Original Assignee
Lice Up Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lice Up Ltd filed Critical Lice Up Ltd
Publication of EP2306817A1 publication Critical patent/EP2306817A1/de
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/60—Sugars; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00—Antiparasitic agents
    • A61P33/14—Ectoparasiticides, e.g. scabicides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
    • A61Q17/02—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings containing insect repellants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q5/00—Preparations for care of the hair
    • A61Q5/02—Preparations for cleaning the hair
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q5/00—Preparations for care of the hair
    • A61Q5/06—Preparations for styling the hair, e.g. by temporary shaping or colouring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q5/00—Preparations for care of the hair
    • A61Q5/12—Preparations containing hair conditioners

Definitions

  • the present invention in some embodiments thereof, relates to the field of cosmetics and household remedies for eradication of ectoparasites, and more particularly, but not exclusively, to anti-phthiraptera treatment compositions and methods using the same.
  • Lice Infestation of the body by lice and other phthiraptera and parasitic insects is an age old problem, and reference to these pests can be found throughout documented human history. Lice have been responsible for the spread of typhus, causing decimation of armies and navies of the military powers of the 15 th to 18 th centuries. Lice are still considered as disease vectors and present serious health problems throughout the world; not only do lice carry a wide variety of bacteria on their exterior surfaces, but their fecal matter transmits disease when it enters the puncture wounds lice inflict during feeding.
  • the human lice genus includes pubic lice, body lice and head lice, each having specific characteristics with regard to habitat and feeding.
  • the most common, namely the head lice, are small hard-shelled ectoparasites which cling to hair follicles while feeding, mating and laying eggs.
  • the louse must remain on the head as it will die within a short period of time when removed.
  • Ideal conditions include an adequate food supply, environmental temperatures from about 28 0 C to about 32 0 C, and relative humidity from about 70 % to about 90 %. Poor hygienic and grooming habits are also known to contribute significantly to the spread of lice, thus, lice infestations are most serious in tropical areas where the inhabitants have both substandard hygienic facilities and practices.
  • the louse's hard chitinous shell serves as protection from external elements.
  • Lice eggs ova
  • a chitinous sheath surrounding the eggs and attached to the hair follicles are similarly protected by a chitinous sheath surrounding the eggs and attached to the hair follicles.
  • the lice may be affected by the use of an insecticide, often the ova remain resistant to attack.
  • the optimum treatment should kill the nymph and adult lice and interrupt the gestation of the ova.
  • Biologically-active agents for the control of lice are well known in the art. Lindane (gamma-benzene hexachloride), synergized natural pyrethrins, and synthetic derived compounds known as pyrethroids have all been used as pediculicides in lice treatment compositions. However, since lindane has a poor safety profile and lice have developed a significant degree of resistance to it, natural pyrethrins and synthetic pyrethroids are routinely chosen for use in pediculicide and ovicide compositions.
  • Natural pyrethrins are made from extracts of naturally insecticidal chrysanthemum flowers and have been used since the early 1930's.
  • European Patent Application 191,236; European Patent Application 262,885; and British Patent Specification 1,593,601 all disclose the use of natural pyrethrins for treating lice.
  • U.S. Patent No. 4,668,666, teaches that natural pyrethrins 1 poor environmental stability is a severe drawback in treatment of lice, as its low residual action, due to this instability, necessitates frequent follow-up treatments.
  • Synthetic pyrethroids became popular during World War II when chrysanthemum flowers became scarce. Besides being cheaper and more readily available, these agents were also somewhat more stable than the natural product. This long-term stability extended toxicity to future hatching ova. Although more effective against lice than natural pediculicides in general, some of the synthetic actives are more toxic to the subject being treated. Other anti-lice formulations eliminating insecticides are known in the art.
  • Alkanols are known to effectively control head lice infestations.
  • British Patent Specification 1,604,857 and European Application 262,885 disclose the use of alkanols, either singularly or as adjuvants, as anti-lice agents.
  • Primary as well as aromatic alkanols are disclosed therein as components of anti-lice compositions, such as sprays and shampoos.
  • Cationic surfactants are known to synergize pediculicides, as disclosed in British Patent Specification 1,593,601.
  • U.S. Patent No. 4,183,913 specifically discloses the use of quaternary ammonium salts to synergize pediculicides.
  • Quaternary ammonium salts are disclosed as a stand-alone pediculicide for head lice in European Patent Application 191,236.
  • U.S. Patent No. 5,518,736 discloses a method of preparing natural-oil- containing emulsions and microcapsules, and their uses for fighting head lice, by teaching a sustained-release biodegradable lice repelling preparation comprising, in the form of an aqueous emulsion, at least one natural oil, an anionic emulsifier and chitosan.
  • the present invention in some embodiments thereof, relates to a composition for eradication of ectoparasites, and more particularly, but not exclusively, to anti- phthiraptera treatment compositions, hair care formulations containing same and methods utilizing the same.
  • the compositions and hair care formulations are based on an emulsion of a film-forming carbohydrate and oil which practically kills lice and other insects including their ova, and in the case of ectoparasites that live on human hair, loosens the grip of the insects to the hair, thereby making the mechanical removal thereof much more effective.
  • a hair care formulation comprising from about 20 weight percents to about 60 weight percents of a liquid ovicidal/pediculicidal composition, the liquid ovicidal/pediculicidal composition comprising: a film-forming carbohydrate in an amount that ranges from about 5 weight percents to about 50 weight percents; and water.
  • the hair care formulation being identified for eradicating a population of at least one ectoparasite.
  • the formulation is being washable within a time period of less than 5 minutes from hair at a length of 5 cm under water shower stream of 20 liters per minutes and a water temperature of 37 0 C.
  • the formulation is washable within a time period of less than 1 minute from hair at a length of 5 cm under water shower stream of 20 liters per minutes and a water temperature of 37 0 C.
  • the composition further comprises oil in an amount that ranges from about 1 weight percent to about 20 weight percents of the total weight of the composition.
  • the composition further comprises an emulsifier in an amount that ranges from about 0.5 weight percent to about 5 weight percents of the total weight of the composition.
  • the formulation is in a form selected from the group consisting of a shampoo, a conditioner, a mask, a mousse, a gel, a hairspray, a lotion, a moisturizer, a tonic and a serum.
  • the ectoparasite is selected from the group consisting of Pediculus humanus capitis (head lice), Pediculus humanus corporis, Phthir us pubis, Cimicidae Cimex lectularius and Sarcoptes scabiei.
  • the ectoparasite is Pediculus humanus capitis.
  • the film-forming carbohydrate is selected from the group consisting of a monosaccharide, a disaccharide, a polysaccharide, a purified saccharide, an impure saccharide, a crude saccharide, a mixture of saccharides, molasses, syrup, treacle and any combination thereof.
  • the film-forming carbohydrate comprises at least one substance selected from the group consisting of allose, altrose, arabinose, a beet-sugar syrup, a cane-sugar syrup, a corn syrup, cellobiose, deoxyribose, dextrose, erythrose, erythrulose, fructose, fructose syrup, fucose, fructan, galactitol, galactosamine, galactose, gentiobiose, gluconic acid, glucosamine, glucose, glucose syrup, glucuronic acid, glycerol (glycerine), gulose, a high fructose starch-based syrup (HFSS), a high-fructose corn syrup (HFCS), idose, inositol, isomalt, isoglucose, isomaltose, isomaltulose/palatinose, lactitol
  • HFSS high fructo
  • the film-forming carbohydrate is glucose syrup having a dextrose equivalent value (DE) lower than 55.
  • the film-forming carbohydrate is glucose syrup having a dextrose equivalent value (DE) lower than 45.
  • the film-forming carbohydrate is glucose syrup having a dextrose equivalent value (DE) of 42.
  • the oil is selected from the group consisting of acai oil, agarwood oil, algae oil, allspice oil, almond oil, amaranth oil, amur cork tree fruit oil, anise oil, apple seed oil, apricot oil, argan oil, artichoke oil, avocado oil, babassu oil, balanos oil, basil oil, bay leaf oil, ben (moringa oleifera) oil, bergamot oil, blackcurrant seed oil, bladderpod oil, borage seed oil, borneo tallow nut oil, bottle gourd oil, brucea javanica oil, buffalo gourd oil, burdock (bur) oil, camphor oil, candlenut (kukui nut) oil, cannabis oil, canola oil, cape chestnut (yangu) oil, carob pod oil, carrot seed oil, cashew oil, cassia oil, castor oil, cedar oil , celery oil, chamomile oil, chaulmoo
  • the emulsifier is selected from the group consisting of cationic emulsifier, an anionic emulsifier, a non-ionic emulsifier and combinations thereof.
  • the emulsifier is selected from the group consisting of sodium dodecyl sulfate, a phospholipid, a glycolipid, a triglyceride, lecithin, soap, sodium stearate, potassium stearate, ammonium stearate, sodium oleate, potassium oleate, ammonium oleate, sodium palmitate, potassium palmitate and ammonium palmitate.
  • the formulation in a form of a shampoo further comprising at least one ingredient selected from the group consisting of a detergent or surfactant, a salt, an acid and a humectant.
  • the formulation further comprises an additional ingredient selected from the group consisting of a fragrant, a colorant, a polydimethylsiloxane, a quaternary ammonium derivative of natural guar gum, a protein, an amino acid, a vitamin, a provitamin, a botanical extract, a UV protectant, an antioxidant, a medically active agents and any combination thereof.
  • the formulation is in a form of a conditioner, the formulation further comprising at least one ingredient selected from the group consisting of a moisturizer/humectant, an emulsifier, a reconstructor, an acid and a buffer.
  • the formulation is further comprising an additional ingredient selected from the group consisting of a fragrant, a colorant, a hydrolyzed protein, a detangler, a thermal protector, a glossers, oil, an essential fatty acid, a cationic surfactant, a lubricant, a an fatty alcohol, a sequestrant, an antistatic agent, a preservative and any combination thereof.
  • an additional ingredient selected from the group consisting of a fragrant, a colorant, a hydrolyzed protein, a detangler, a thermal protector, a glossers, oil, an essential fatty acid, a cationic surfactant, a lubricant, a an fatty alcohol, a sequestrant, an antistatic agent, a preservative and any combination thereof.
  • the formulation is in a form of a hairspray, the further comprising at least one ingredient selected from the group consisting of a fixing agent, an alcohol, a surfactant, an emulsifier, a propellant, a polydimethylsiloxane, an alkylacrylamide/acrylate copolymer.
  • the formulation further comprises an additional ingredient selected from the group consisting of a fragrant, a colorant, a lubricant, an antistatic agent, hair setting polymer, a preservative and any combination thereof.
  • a process for preparing the hair care formulation as described herein comprising: adding the liquid ovicidal/pediculicidal composition as described herein into a formulation of a hair care composition selected from the group consisting of a shampoo, a conditioner, a mask, a mousse, a gel, a hair spray, a lotion, a moisturizer, a tonic and a serum.
  • a hair care composition selected from the group consisting of a shampoo, a conditioner, a mask, a mousse, a gel, a hair spray, a lotion, a moisturizer, a tonic and a serum.
  • a method of eradicating a population of at least one ectoparasite in human hair comprising: (a) applying a disinfesting effective amount of the hair care formulation of any of claims 1-22 to wet hair; (b) leaving the formulation on the hair and scalp for a pre-determined time period; and (c) rinsing the formulation from the hair.
  • the pre-determined time period ranges from 1 minute to 20 minutes. According to some embodiments of the invention, the pre-determined time period ranges from 1 minute to 10 minutes.
  • the pre-determined time period ranges from 1 minute to 6 minutes.
  • the effective amount ranges from 10 grams to 30 grams of the hair care formulation.
  • the method is further comprising, subsequent to the applying, working the formulation through the hair and scalp.
  • a liquid ovicidal/pediculicidal composition comprising: a film-forming carbohydrate, as described herein, as described herein, in an amount that ranges from about 5 weight percents to about 50 weight percents; and water, the composition being identified for eradicating a population of at least one ectoparasite, as described herein.
  • the liquid ovicidal/pediculicidal is further comprising oil, as described herein, in an amount that ranges from about 1 weight percent to about 20 weight percents of the composition.
  • the liquid ovicidal/pediculicidal is further comprising an emulsifier, as described herein, in an amount that ranges from about 0.5 weight percent to about 5 weight percents.
  • an emulsifier as described herein, in an amount that ranges from about 0.5 weight percent to about 5 weight percents.
  • a process for preparing the liquid/pediculicidal composition described herein comprising: mixing the film-forming carbohydrate, the oil, if present, the emulsifier, if present, and the water.
  • liquid/pediculicidal composition described herein in the manufacture of a hair care formulation for eradicating a population of at least one ectoparasite, as described herein
  • the eradicating a population of at least one ectoparasite is effected by: (a) applying a disinfesting effective amount of the hair care formulation to wet hair, as described herein; (b) leaving the formulation on the hair and scalp for a pre-determined time period, as described herein; and (c) rinsing the formulation from the hair.
  • a compound or “at least one compound” may include a plurality of compounds, including mixtures thereof.
  • % represents the phrase “percentage by weight” in general, and more specifically “percentage by weight of the total weight of a composition/mixture/formulation", unless specified otherwise.
  • composition or method may include additional ingredients and/or steps, but only if the additional ingredients and/or steps do not materially alter the basic and novel characteristics of the claimed composition or method.
  • range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
  • method or “process” refer to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.
  • the present invention in some embodiments thereof, relates to the field of cosmetics and household remedies for eradication of ectoparasites, and more particularly, but not exclusively, to anti-phthiraptera treatment compositions and methods using the same.
  • the inventor has aimed at a solution which would afford multiple objectives, including pediculicidal and ovicidal activity as well as a pest behavior-altering effect, without exerting a toxic load on the treated subject.
  • the rudimentary approach underlying the present invention was set to achieve a long-term pediculicidal and ovicidal activities, while affecting the behavior of the pest so as to make the common mechanical removal of the surviving population far more effective.
  • the film-forming agent is selected such that it is completely benign to the treated subject, and can form a film on the treated area (for example, hair and scalp) at normal living conditions even when the treated area is partially dried or substantially dried.
  • the resulting encapsulating coat formed by the composition is selected so as not to form a crystalline or powdery form at any stage of the treatment which may extend several hours at normal ambient conditions.
  • the inventor has found that many edible or otherwise benign carbohydrates form a film when a solution thereof is dried, as opposed to forming powdery or crystalline sediments. Further research into an optimal composition has revealed that combining a film-forming carbohydrate with edible or otherwise benign oil in a concentrated aqueous solution affords the desired ovicidal/pediculicidal result, while being completely safe and even edible.
  • a composition containing a film- forming carbohydrate should also be washable from the user's hair, namely be easy to rinse-off without leaving residues and other remnants thereof, which was and still is one of the major drawbacks of the old and well-known home-made and folkloric anti-lice remedies.
  • This capacity to wash-off can be defined by a time period of less than 5 minutes, and even less than 1 minute, in which the composition will be rinsed-off from typical human hair of less than 60 cm in length, using a typical showerhead or another water delivery mechanism, flowing water at a rate of at least 5 liters per minute and at a typical showering temperature of less than 40 0 C.
  • the ovicidal/pediculicidal composition can be used as a part of a hair care formulation, thereby rendering its use more agreeable and comfortable for the user, by being washable and having the more familiar form of an everyday use product.
  • washable and highly efficacious anti-ectoparasitic formulations were realized in the form of a hair care product, such as shampoos, hair conditioners, sprays and the likes.
  • the inventor has used an exemplary shampoo formulation having a content of 10 weight percents glucose syrup and 1 percent canola oil, and the surprising results indicated that the heads of about 30 lice-infested children no longer had any remnants of lice after one or two uses of the shampoo.
  • the hair care formulation presented herein has a dual effect, one as an anti-ectoparasitic formulation, and one as a hair care formulation for everyday use.
  • hair care formulation refers to a formulation of substances which are combined so as to impart a beneficial or desired effect in hair, and include formulations known by their common names, such as a shampoo, a conditioner, a mask, a mousse, a gel, a hairspray, a lotion, a moisturizer, a tonic and a serum.
  • hair care formulation is also referred to, interchangeably as "formulation”.
  • the hair care formulation is an anti-ectoparasitic formulation, being capable of, and identified for use in, eradicating a population of ectoparasites.
  • the formulation is washable, as discussed hereinafter.
  • the hair care formulation described herein comprises from about 10 weight percents to about 60 weight percents of a liquid ovicidal/pediculicidal composition.
  • the hair care formulation comprises from about 20 weight percents to about 60 weight percents of a liquid ovicidal/pediculicidal composition.
  • a lower or higher concentration of the liquid composition is used, as long as the desired physicochemical properties, as detailed hereinbelow, of the formulation can be achieved.
  • the liquid ovicidal/pediculicidal composition comprises: a film-forming carbohydrate in an amount that ranges from about 5 weight percents to about 50 weight percents; and water.
  • Water is added in an amount required to complete said composition to 100 weight percents.
  • the hair care formulation is washable within a time period of less than 5 minutes from hair at a length of 5 cm in a water shower stream of 20 liters per minute and a water temperature of 37 0 C. In some embodiments, the hair care formulation is washable within a time period of less than 4 minutes, less than 3 minutes, less than 2 minutes, less than 1 minutes and even less than 30 seconds or less than 20 seconds, under the above- indicated conditions. It is to be understood that while the hair care formulation described herein may require longer time periods for being washed off hair at higher or shorter lengths, the washability of the formulation is determined by the above-indicated conditions.
  • water shower stream describes stream of water coming out from all types of available shower heads, including fixed, positionable and handheld shower heads, shower heads equipped with a selector for multiple spray patterns, as long as the indicated conditions of water stream and temperature are maintained for determining the time period required for washing the formulation from the hair.
  • washable it is meant that at least most, if not all, of a formulation that has been applied to the hair has been washed off the hair, such that the hair no longer feels “soapy” or otherwise wetted by ingredients other than water.
  • the hair care formulation described herein has similar washability as that of commercially available shampoos, conditioners and the like.
  • the liquid ovicidal/pediculicidal composition further comprises oil.
  • the composition comprises oil in an amount that ranges from about 1 weigh percents to about 20 weigh percents of the total weight of the composition.
  • liquid ovicidal/pediculicidal composition describes a composition which is in a liquid state before use, and which when comes in contact with a nymph, adult or ova of an insect ectoparasite, such as phthiraptera, is capable of eradicating and/or devitalizing by exposure thereto and contact therewith a major portion of the population of the nymph, adult and/or ova thereof.
  • composition The liquid ovicidal/pediculicidal composition is also referred to herein throughout simply as “composition” or “liquid composition”.
  • eradicating and/or devitalizing it is meant that the population of the nymph, adult and/or ova of the ectoparasite is reduced or eliminated to the extent that it can no longer be detected and can no longer re-appear without an external source of individuals which were not members of the eradicated population at the time of exposure to the ovicidal/pediculicidal composition according to some embodiments of the invention.
  • eradicating a major portion of the ectoparasite's population is manifested by killing or devitalizing at least 60 %, at least 70 %, at least 80 %, at least 90 % and even 100 % of the ectoparasites.
  • the liquid ovicidal/pediculicidal composition comprises ingredients which are officially accepted as safe, or in other words, are classified as GRAS (Generally Accepted As Safe) by the national agencies which are responsible for regulations in the food and drug fields.
  • GRAS Generally Accepted As Safe
  • liquid ovicidal/pediculicidal composition described herein consists essentially of ingredients which are officially accepted as safe, as defined herein.
  • the film-forming carbohydrate included in the composition described herein as the active ingredient can be in an amount of, for example, 5, 10, 15, 20, 25, 30, 35, 40, 45 and 50 weight percents of the total weight of the composition.
  • film-forming carbohydrate refers to soluble carbohydrates or saccharides, which form a film on a surface when a solution thereof is dehydrated, dried, exposed to body temperature or to a combination of these conditions, as opposed to carbohydrates or saccharides which leave a powdery or crystalline residue or sediment when a solution thereof is exposed to any one or a combination of these conditions.
  • carbohydrate is used herein and in the art to describe a chemical substance, either naturally occurring or synthetic, which is mainly composed of carbon, hydrogen and oxygen atoms.
  • the term “carbohydrate” is often used in the art to collectively describe saccharides and sugars, including monosaccharides, disaccharides, oligosaccharides, polysaccharides, and derivatives thereof, as detailed herein.
  • monosaccharide refers to a simple form of a sugar that consists of a single saccharide unit which cannot be further decomposed to smaller saccharide building blocks or moieties. Most common examples of monosaccharides include glucose (dextrose), fructose, galactose, mannose, and ribose.
  • Monosaccharides can be classified according to the number of carbon atoms of the carbohydrate, i.e., triose, having 3 carbon atoms such as glyceraldehyde and dihydroxyacetone; tetrose, having 4 carbon atoms such as erythrose, threose and erythrulose; pentose, having 5 carbon atoms such as arabinose, lyxose, ribose, xylose, ribulose and xylulose; hexose, having 6 carbon atoms such as allose, altrose, galactose, glucose, gulose, idose, mannose, talose, fructose, psicose, sorbose and tagatose; heptose, having 7 carbon atoms such as mannoheptulose, sedoheptulose; octose, having 8 carbon atoms such as 2-keto
  • the monosaccharide can be a monosaccharide derivative, in which the saccharide unit comprises one or more substituents other than hydroxyls.
  • Such derivatives can be, but are not limited to, ethers, esters, acids, phosphates and amino saccharides.
  • Oligosaccharides are commonly defined in the art and herein as being composed of up to nine saccharide units (see, for example, Roberts, J. D., and Caserio, M. C, Basic Principles of Organic Chemistry (1964) p. 615).
  • Representative examples include, without limitation, disaccharides such as, but not limited to, sucrose, maltose, lactose, and cellobiose; trisaccharides such as, but not limited to, mannotriose, raffinose and melezitose; and tetrasaccharides, such amylopectin, Syalyl Lewis X (SiaLex) and the like.
  • polysaccharide as used herein is meant to include compounds composed of 10 saccharide units and up of hundreds and even thousands of monosaccharide units per molecule, which are held together by glycoside bonds and range in their molecular weights from around 5,000 and up to millions of Daltons.
  • polysaccharides examples include, but are not limited to starch, glycogen, cellulose, gum arabic, agar and chitin.
  • sugars and saccharides are less likely to form powdery or crystalline residue or sediment from a solution thereof even when the solution is prepared from the purified, due to their multi-conformational structure.
  • Sugars are also highly hygroscopic, making a dry and powdered form thereof hard to maintain at normal ambient conditions.
  • sugars and saccharides are not purified so as to be regarded as a single chemical species, but tend to contain deliberate or consequential impurities as a side-product of their mass production.
  • Other sugars and saccharides are available only as mixtures of several and sometime a great number of carbohydrate species, and some are known and sold as syrups.
  • a suitable "film-forming carbohydrate”, according to embodiments of the present invention is selected such that when an aqueous solution thereof is exposed to dehydration and/or body temperature, a sticky film is formed.
  • film-forming carbohydrate as described herein form a sticky film when in contact with a body surface either due to its impure state (being a mixture of species at a certain species distribution), due to its hygroscopic character, or both.
  • the film-forming carbohydrate may be composed of monosaccharides, disaccharides, oligosaccharides, and polysaccharides, as defined herein, each being pure, purified or impure; of crude saccharides; mixtures of saccharides; molasses; syrups; treacle and any combination thereof, as long as they are capable of forming a film when an aqueous solution thereof is exposed to dehydration and/or body temperature.
  • some polysaccharides are known to form powdery and dry sediments rather than a sticky film even when present in non-uniform mixtures.
  • chitosan and some other by-products of chitin and chitin breakdown products are less suitable as film-forming carbohydrates in the context of the present embodiments.
  • Exemplary film-forming carbohydrates that are suitable for use in the context of embodiments of the invention include, but are not limited to, allose, altrose, arabinose, a beet-sugar syrup, a cane-sugar syrup, a corn syrup, cellobiose, deoxyribose, dextrose, erythrose, erythrulose, fructose, fructose syrup, fucose, fructan, galactitol, galactosamine, galactose, gentiobiose, gluconic acid, glucosamine, glucose, glucose syrup, glucuronic acid, glycerol (glycerine), gulose, a high fructose starch-based syrup (HFSS), a high-fructose corn syrup (HFCS), idose, inositol, isomalt, isoglucose, isomaltose, isomaltulose/palatinose, lactito
  • glucose syrup affords a highly efficacious liquid ovicidal/pediculicidal composition which can form a part of an effective anti-ectoparasitic hair care formulation.
  • saccharide refers to a thick and viscid and oftentimes saturated aqueous solution of a saccharide or a mixture or saccharides and other carbohydrates.
  • Glucose is formed in plants from carbon dioxide absorbed from the air using sun light as energy source.
  • part of the glucose is polymerized into long chains of glucose and stored as starch in granules as a reserve.
  • starch is broken down again by enzymes (e.g., amylase) to support new growth.
  • enzymes e.g., amylase
  • This break down of starch can be imitated in factories by applying acid or enzymes to cooked aqueous solutions of starch. These reactions cause the starch to hydrolyze into a variety of mixtures of glucose and intermediates, and the common way to characterize these various mixtures is by their DE number.
  • dextrose monohydrate Only glucose solution of high DE can crystallize easily and yield a powdery or granular form of a residue or sediment.
  • the most commonly used and known crystallized product of glucose is dextrose monohydrate, with applications in, for example, medicine and as chewing tablets for athletes, therefore, for all intents and purposes of everyday life, dextrose monohydrate is pure glucose.
  • a less purified product known as "Total Sugar” is produced by instant crystallizing a 97 DE syrup leaving no hydrol (mother liquor) to dispose off.
  • the syrup loose gradually its tendency to crystallize and below approximately 45 DE the syrup can be evaporated into a stable, non-crystallizing and auto sterile liquid due to a water activity level which is low so as to prevent any form of microbial life therein.
  • glucose syrup which is prepared by having the starch hydrolyzed by acid or enzymes to 40 - 42 DE, and evaporated to a viscous liquid with a dry matter of 80-84 weight percents.
  • Glucose Syrup 80/42 or simply "42 DE"
  • This standard product has a bland sweet taste; stores and ship well in drums or tank lorries.
  • the relative sweetness of 42 DE to sucrose is 40-45 weight percents, and it find applications in canned fruit preserves, ice cream, bakery products, jam, soft drinks, candy and all kinds of confectionery, as well as a booster in the fermentation of alcohol.
  • the film-forming carbohydrate is glucose syrup, such as, for example, Glucose Syrup 80/42.
  • syrup of other carbohydrates is used.
  • composition described herein comprises a film-forming carbohydrate in an aqueous solution, as described herein.
  • the composition further comprises oil.
  • oil in the composition contributes to the pediculicidal effect of the composition. It is postulated that together with the film-forming carbohydrate in water, oil forms a bi- physic system that can readily encapsulate the ectoparasite and cause loosening of its grip.
  • oil attributes to the physicochemical properties of the obtained hair care formulations, as it may render the formulation washable, and may further be used to stabilize the formulation and/or composition described herein.
  • the liquid ovicidal/pediculicidal composition further includes oil in an amount that ranges from about 1 weight percents to about 20 weight percents of the composition.
  • the oil can amount to about 1, 2, 6, 8, 10, 12, 14, 16, 18 and 20 weight percents.
  • the natural phenomenon of the organic phase (oil droplets) rising up from within the aqueous phase causes the film-forming carbohydrate solution to move toward the bodies and ova of the insect, causing the film-forming carbohydrate solution to coat the bodies and ova of the insects due to the similar chemistry of the film-forming carbohydrate and the chitinous shells of the insect nymph, adult and ova, as discussed hereinabove.
  • the ovicidal/pediculicidal compositions and hair care formulations described herein are formulated such that the individual parasitic specimen sinks or partly sinks in the liquid composition or hair care formulation due to the unique emulsion or otherwise bi-phasic combination of liquids having favorable characteristics of surface tension (wettability) and specific gravity with respect to the insect shell and body mass and density.
  • wettability surface tension
  • specific gravity specific gravity
  • the oil can be any benign and possibly edible oil, so as not to involve toxic elements in the composition; however the oil is not required to be edible as long as it is safe for external use in mammalian subjects under indicated conditions.
  • Some aromatic oils and other essential oils are known to have some anti-insect activity, insect repellent activity and even insecticidal activity. In the context of some embodiments of the invention, such oils having anti-ectoparasitosis activity are highly suitable for use in the compositions presented herein.
  • aromatic and essential oils may be selected for the present composition in small amounts while the bulk of the oil may be selected from more commercially and/or economically available oils since the oil in the present composition can merely be used to form a bi- phasic system with the aqueous solution of the film-forming carbohydrate.
  • the oil can be a single type of oil or a combination of more than one type of oil.
  • Exemplary oils that are suitable for use in the context of embodiments of the invention include, but are not limited to, acai oil, agarwood oil, algae oil, allspice oil, almond oil, amaranth oil, amur cork tree fruit oil, anise oil, apple seed oil, apricot oil, argan oil, artichoke oil, avocado oil, babassu oil, balanos oil, basil oil, bay leaf oil, ben (moringa oleifera) oil, bergamot oil, blackcurrant seed oil, bladderpod oil, borage seed oil, borneo tallow nut oil, bottle gourd oil, brucea javanica oil, buffalo gourd oil, burdock (bur) oil, camphor oil, candlenut (kukui nut) oil, cannabis oil, canola oil, cape chestnut (yangu) oil, carob pod oil, carrot seed oil, cashew oil,
  • the oil is grape seed oil.
  • the oil is canola oil and/or jojoba oil.
  • the oil further comprises rosemary oil, turmeric oil, and any other oil that exhibits an anti-ectoparasitosis activity.
  • the choice of oil can be made according to the taste and preference of the user, and according to the mode of use of the composition.
  • the composition can be incorporated into a hair care product, such as a shampoo having a fragrance therein, the choice of oil should take into account the desired final smell of the product, and possibly be an odorless oil.
  • an odorless shampoo composition may relay of the selection of fragrant oil for its smell, hence essential aromatic oil should be selected.
  • the liquid ovicidal/pediculicidal composition further includes an emulsifier.
  • emulsifier also known as a surfactant or a surface active agent
  • emulsifier refers to a substance which stabilizes an emulsion.
  • the emulsion as commonly known, is provided by preparing and mixing two solutions, one being the aqueous phase (water-based phase) and another being the organic phase (oil-based phase), so as to disperse one phase in the other.
  • an emulsion is an "oil-in-water" emulsion, wherein droplets of the oil are dispersed in the continuous aqueous phase.
  • the amount of the emulsifier ranges from about 0.5 weight percents to about 5 weight percents of the total weight of the composition.
  • Exemplary emulsifiers that are suitable for use in the context of embodiments of the invention include, but are not limited to, sodium dodecyl sulfate, a phospholipid, a glycolipid, a triglyceride, lecithin, soap, sodium stearate, potassium stearate, ammonium stearate, sodium oleate, potassium oleate, ammonium oleate, sodium palmitate, potassium palmitate and ammonium palmitate.
  • the liquid ovicidal/pediculicidal composition presented herein is packaged in a packaging material and is identified in print, in or on the packaging material, for use in a treatment against insect ectoparasites in general and human head lice in particular.
  • a process of preparing the liquid ovicidal/pediculicidal composition described herein which is effected by adding a pre-determined amount of the film-forming carbohydrate to water, optionally adding a predetermined amount of the oil, optionally adding a predetermined amount of the emulsifier, adding water to the final weight of the composition, and mixing the resulting mixture so as to obtain a homogeneous mixture thereof.
  • the liquid ovicidal/pediculicidal composition presented herein is used in the manufacture of a hair care formulation which is identified for use against insect ectoparasites in general and human head lice in particular, as described herein.
  • a hair care formulation When incorporating the liquid ovicidal/pediculicidal composition presented herein into a hair care product (a hair care formulation), the obtained hair care formulation is regarded as an ovicidal/pediculicidal hair care formulation with the liquid ovicidal/pediculicidal composition presented herein as an active ingredient.
  • the amount of the liquid ovicidal/pediculicidal composition which is incorporated as a single liquid blend of ovicidal/pediculicidal composition described hereinabove ranges from about 10 weight percents to about 60 weight percents of the total weight of the hair care formulation, as detailed hereinabove.
  • a hair care formulation can be formulated according to well-established experience accumulated in the art, into a variety of products, such as shampoos, conditioners, masks, mousses, gels, sprays, lotions, moisturizers, tonics serums and the likes.
  • the hair care formulation which is infused with the anti-ectoparasite composition presented herein is a shampoo product for the eradication of, for example, head lice in humans.
  • a shampoo is a hair care product which is typically used for the removal of bodily secreted fats and oils, dead skin particles, dandruff and other bodily debris, environmental dirt and other pollutants and other contaminant particles that gradually build up in the hair and on the scalp.
  • the general objective of shampoos is to remove the unwanted build-up without stripping off the hair which may damage it or harm the scalp skin.
  • a shampoo when lathered with water, is a surfactant, which, while cleaning the hair and scalp, can remove the natural oils (sebum) which lubricate the hair shaft.
  • Typical shampoo ingredients include one or more, and any combination of:
  • a detergent which is typically a salt of a fatty acid, such as an ammonium or sodium form of lauryl or laureth sulfate;
  • a salt such as ammonium chloride
  • Acids such as alpha-hydroxy acids
  • Humectants such as glycols
  • Polymeric organosilicon and polydimethylsiloxane such as dimethicone; Quaternary ammonium derivatives of natural guar gum, such as Guar hydroxypropyltrimonium chloride;
  • Proteins and/or amino acids Proteins and/or amino acids; Vitamins and provitamins;
  • UV protectant
  • Antioxidants and optionally, additional medications or other medically active agents (anti- dandruff etc.).
  • the hair care formulation which is infused with the anti-ectoparasite composition presented herein is a hair conditioning product, or a hair conditioner for the eradication of, for example, head lice.
  • conditioner is a hair care product which is typically used for altering the texture and appearance of human hair.
  • conditioners include one or more, and any combination of: Moisturizers and humectants for maintaining a relatively high level of moisture in the hair;
  • Reconstructors in the form of hydrolyzed proteins which are said to penetrate the hair and strengthen its structure through biopolymer crosslinking;
  • Acidifiers and buffers which maintain the conditioner's pH at about 2.5-3.5, which is said to cause scaly scalp surface to tighten-up due to strengthening of the hydrogen bonds between the keratin molecules.
  • Thermal protectors in the form of heat-absorbing polymers, shielding the hair against excessive heat, caused by, e.g., blow-drying or curling irons or hot rollers.
  • Glossers which are light-reflecting chemicals that can bind to the hair surface, such as silicone-bases polymers such as dimethicone or cyclomethicone;
  • Surfactants such as cationic surfactants, which don't wash off completely in water, because their hydrophilic ends strongly bind to keratin in the hair;
  • Lubricants such as fatty alcohols, panthenol, dimethicone and the likes;
  • Sequestrants for better function in hard water
  • Preservatives are known to be used in hair care products, subject to particular requirements and preference, and include:
  • Alkalinity Source Increases the alkalinity of the product to aid dissolution of dirt
  • Antidandruff Agent Controls dandruff
  • Antifoaming Agent Suppresses the formation of excess foam during production and/or consumer use
  • Antimicrobial Agent Added to cosmetic products to help reduce the activities of micro-organisms on the skin or body; Antioxidant - Inhibits the product reacting with oxygen, which can cause product spoilage;
  • Antiperspirant Agent The active component that reduces perspiration
  • Anti-redeposition Agent Prevents dirt in the wash solution being re-deposited on the clothes;
  • Antistatic Agent Prevents static charges on human surfaces e.g. skin/hair or on clothes;
  • Astringent Induces a tightening or a tingling sensation on the skin
  • Binder - Substances which provide adhesive properties so that the solids stick together e.g. tablets, eye shadow;
  • Botanicals Ingredients derived from plants e.g. Aloe Vera;
  • Buffering Agent Adjusts or stabilizes the acidity/alkalinity of a product
  • Cooling Agent Makes the skin feel cooler; Corrosion Inhibitor - Prevents corrosion of the packaging;
  • Deodorant Agent Reduces or masks unpleasant body odors
  • Emulsifier Used in small quantities that help to form or stabilize immiscible liquids in an emulsion
  • Emulsion Stabilizer Improves stability of an emulsion and increases shelf life of product
  • Evaporation Aid Helps the product dry faster after application;
  • Exfoliating Agent Helps remove dead skin cells from the surface;
  • Film Former Makes product form a uniform film when applied to a surface;
  • Fixing Agent Maintains the hold/shape of a hair style;
  • Fragrance Makes the product smell nice in the packaging and during use;
  • Hair Conditioning Agent Enhances the appearance and texture of the hair, improves gloss, sheen and texture of damaged hair, and facilitates styling;
  • Hair Waving/Straightening Agent Modifies hair fibers to facilitate configuration changes
  • Humectant - Holds/retains water in the product, and/or increases the moisture content in the top layers of the skin;
  • Hydrotrope Increases the solubility of the detergent in the product
  • Opacifier Reduces the transparency/translucency of a product, may give a pearly appearance
  • Oxidizing Agent Remove hair colorants or stabilize the hair after perming; Pearlescer - Gives sheen to a liquid, which can be seen as flow lines when poured; pH Adjuster - Adjusts the acidity/alkalinity of products; Plasticizer - Reduces product brittleness and modifies flow properties;
  • Preservative Protects products from microbial growth and spoilage from accidental contamination by the consumer during use;
  • Propellant - Delivers the product from an aerosol
  • Reducing Agent Changes the chemical nature of another substance by adding hydrogen or removing oxygen
  • Sequestrant Prevents free metal ions from causing any adverse effects on product performance, appearance, or stability by reacting with them;
  • Skin Conditioning Agent Help to keep the skin soft, smooth, pliable and healthy looking
  • Skin Protectant Protects the skin from the influences of the external environment;
  • Slip Modifier Enhances the physical flow characteristics of the product;
  • Softness Extender Improves the effectiveness of a softening agent
  • Solubilizer Improves the solubility of one or more product ingredients
  • Spray Modifier Modifies the spray characteristics of a spray; Stabilizing Agent - Maintains ingredient or formulation stability;
  • Structurant Gives form or shape to final products
  • Surfactant Changes the surface tension of water to assist cleansing, wetting surfaces, foaming and emulsifying (the suspension of one liquid evenly within another);
  • Suspending/Dispersing Agent Aids the even dispersal of a solid within a liquid
  • UV Absorber Filters UV rays to protect the product or skin/hair from UV damage; Viscosity Controlling Agent - Controls the thickness of the product.
  • the hair care compositions of the present invention may be formulated into a wide variety of product types, including shampoos, conditioners, mousses, gels, lotions, tonics, sprays and the likes.
  • the additional components required to formulate such products varies with product type and can be chosen by one skilled in the art of hair care formulation. The following is a description of some examples of these additional components.
  • Exemplary surfactants useful in the compositions and/or formulations of embodiments of the present invention include, but are not limited to, anionic, nonionic, cationic, zwitterionic and amphoteric surfactants.
  • Surfactants are preferred optional ingredients in the hair care formulations described herein, particularly shampoo and conditioner products.
  • the surfactant comprises from about 0.05 weight percents to about 50 weight percents of the total weight of the formulation.
  • the level is typically from about 10 to about 30 weight percents, or alternatively from about 12 to about 25 weight percents of the total weight of the formulation.
  • the level of surfactant is typically from about 0.2 weight percents to about 3 weight percents.
  • Exemplary synthetic anionic detergents useful herein, particularly for the shampoo formulations include, but are not limited to, alkyl and alkyl ether sulfates. These materials have the respective formulae ROSO 3 M and RO(C 2 H 4 O) x SO 3 M wherein R is alkyl or alkenyl of about 10 to about 20 carbon atoms, x is 1 to 10, and M is a water-soluble cation such as ammonium, sodium, potassium and triethanolamine.
  • the alkyl ether sulfates useful in the context of the present embodiments are condensation products of ethylene oxide and monohydric alcohols having about 10 to about 20 carbon atoms.
  • R has from 12 to 18 carbon atoms in both the alkyl and alkyl ether sulfates.
  • the alcohols can be derived from fats, e.g., coconut oil or tallow, or can be synthetic. Lauryl alcohol and straight chain alcohols derived from coconut oil are preferred herein. Such alcohols are reacted with to 10, and especially 3, molar proportions of ethylene oxide and the resulting mixture of molecular species, having, for example, an average of 3 moles of ethylene oxide per mole of alcohol, is sulfated and neutralized.
  • alkyl ether sulfates include, but are not limited to, sodium coconut alkyl triethylene glycol ether sulfate; lithium tallow alkyl triethylene glycol ether sulfate; and sodium tallow alkyl hexaoxyethylene sulfate.
  • Extensively used alkyl ether sulfates are those comprising a mixture of individual compounds, said mixture having an average alkyl chain length of from about 12 to 16 carbon atoms and an average degree of ethoxylation of from about 1 to 4 moles of ethylene oxide.
  • Such a mixture also comprises from about 0 to 20 weight percents C 12-13 compounds; from 60 to 100 weight percents of C 14-1S-16 compounds, from about 0 to 20 weight percents of C 17-1S-1 Q compounds; from about 3 to 30 weight percents of compounds having a degree of ethoxylation of 0; from about 45 to 90 weight percents of compounds having a degree of ethoxylation of from 1 to 4; from about 10 to 25 weight percents of compounds having a degree of ethoxylation of from 4 to 8; and from about 0.1 to 15 weight percents of compounds having a degree of ethoxylation greater than 8.
  • anionic surfactants are the water-soluble salts of the organic, sulfuric acid reaction products of the general formula: R 1 -SO 3 -M, wherein Ri is selected from the group consisting of a branched or unbranched hydrocarbon chain, saturated aliphatic hydrocarbon radical having from 8 to 24 carbon atoms, or 12 to 18 carbon atoms; and M is a cation.
  • anionic surfactants are the salts of an organic sulfuric acid reaction product of a hydrocarbon of the methane series, including iso-, neo-, ineso-, and n-paraffins, having 8 to 24 carbon atoms, or 12 to 18 carbon atoms and a sulfonating agent e.g., SO 3 , H 2 SO 4 , oleum, obtained according to known sulfonation methods, including bleaching and hydrolysis.
  • a sulfonating agent e.g., SO 3 , H 2 SO 4 , oleum
  • Other examples include alkali metal and ammonium sulfonated C ⁇ -is-n-paraffins.
  • anionic synthetic detergents include the reaction products of fatty acids esterified with isethionic acid and neutralized with sodium hydroxide where, for example, the fatty acids are derived from coconut oil; sodium or potassium salts of fatty acid amides of methyl tauride in which the fatty acids, for example, are derived from coconut oil.
  • Other anionic synthetic detergents of this variety are set forth in, for example, U.S. Patent Nos. 2,486,921, 2,486,922 and 2,396,278.
  • Still other anionic synthetic detergents include the class designated as succinamates.
  • This class includes such surface active agents as disodium N- octadecylsulfosuccinamate; tetrasodium N-(1 ,2-dicarboxyethyl)-N-octadecylsulfo- succinamate; diamyl ester of sodium sulfosuccinic acid; dihexyl ester of sodium sulfosuccinic acid; dioctyl esters of sodium sulfosuccinic acid.
  • olefin sulfonates having about 12 to about 24 carbon atoms.
  • olefin sulfonates is used herein to mean compounds which can be produced by the sulfonation of ⁇ -olefins by means of uncomplexed sulfur trioxide, followed by neutralization of the acid reaction mixture in conditions such that any sulfones which have been formed in the reaction are hydrolyzed to give the corresponding hydroxy-alkanesulfonates.
  • the sulfur trioxide can be liquid or gaseous, and is usually, but not necessarily, diluted by inert diluents, for example by liquid SO 2 , chlorinated hydrocarbons, etc., when used in the liquid form, or by air, nitrogen, gaseous SO 2 , etc., when used in the gaseous form.
  • the ⁇ -olefins from which the olefin sulfonates are derived are mono-olefins having 12 to 24 carbon atoms, or 14 to 16 carbon atoms.
  • these are straight chain olefins, and include 1-olefins include 1-dodecene; 1-tetradecene; 1-hexadecene; 1-octadecene; 1-eicosene and 1-tetracosene.
  • the olefin sulfonates can contain minor amounts of other materials, such as alkene disulfonates depending upon the reaction conditions, proportion of reactants, the nature of the starting olefins and impurities in the olefin stock and side reactions during the sulfonation process.
  • the ⁇ -olefins from which the olefin sulfonates are derived are mono-olefins having 12 to 24 carbon atoms or 14 to 16 carbon atoms. According to some embodiments, they are straight chain olefins which include 1-olefins include 1- dodecene; 1-tetradecene; 1-hexadecene; 1-octadecene; 1-eicosene and 1-tetracosene.
  • the olefin sulfonates can contain minor amounts of other materials, such as alkene disulfonates depending upon the reaction conditions, proportion of reactants, the nature of the starting olefins and impurities in the olefin stock and side reactions during the sulfonation process.
  • ⁇ -alkyloxy alkane sulfonates are the ⁇ -alkyloxy alkane sulfonates, as described in the art, e.g., U.S. Patent No. 4,983,383, which is incorporated herein by reference.
  • Non-limiting examples of ⁇ -alkyloxy-alkane-1-sulfonates, or alternatively 2- alkyloxy-alkane-1 -sulfonates, having low hardness (calcium ion) sensitivity useful herein to provide superior cleaning levels under household hair washing conditions include: potassium- ⁇ -methoxydecanesulfonate, sodium 2-methoxy-tridecanesulfonate, potassium 2-ethoxytetradecylsulfonate, sodium 2-isopropoxyhexadecylsulfonate, lithium 2-t-butoxytetradecyl-sulfonate, sodium ⁇ -methoxyoctadecylsulfonate, and ammoni
  • Non-ionic surfactants which are extensively used in combination with an anionic, amphoteric or zwitterionic surfactant, can be broadly defined as compounds produced by the condensation of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound, which may be aliphatic or alkyl aromatic in nature.
  • non-ionic surfactants examples include:
  • Non-ionic surfactants which are polyethylene oxide condensates of alkyl phenols, e.g., the condensation products of alkyl phenols having an alkyl group containing from about 6 to 12 carbon atoms in either a straight chain or branched chain configuration, with ethylene oxide, the ethylene oxide being present in amounts equal to 10 to 60 moles of ethylene oxide per mole of alkyl phenol.
  • the alkyl substituent in such compounds may be derived from polymerized propylene, diisobutylene, octane, or nonane, for example.
  • Non-ionic surfactants derived from the condensation of ethylene oxide with the product resulting from the reaction of propylene oxide and ethylene diamine products which may be varied in composition depending upon the balance between the hydrophobic and hydrophilic elements which is desired.
  • Non-ionic surfactants which are condensation products of aliphatic alcohols having from 8 to 18 carbon atoms, in either straight chain or branched chain configuration, with ethylene oxide, e.g., a coconut alcohol ethylene oxide condensate having from 10 to 30 moles of ethylene oxide per mole of coconut alcohol, the coconut alcohol fraction having from 10 to 14 carbon atoms.
  • ethylene oxide e.g., a coconut alcohol ethylene oxide condensate having from 10 to 30 moles of ethylene oxide per mole of coconut alcohol, the coconut alcohol fraction having from 10 to 14 carbon atoms.
  • Non-ionic surfactants that are long chain tertiary amine oxides, which include, for example, dimethyl-dodecylamine oxide, oleyldi(2-hydroxyethyl) amine oxide, dimethyl-octylamine oxide, dimethyl-decylamine oxide, dimethyl-tetradecylamine oxide, 3,6,9-trioxaheptadecyldiethylamine oxide, di(2-hydroxyethyl)-tetradecylamine oxide, 2-dodecoxyethyldi-methylamine oxide, 3-dodecoxy-2-hydroxypropyldi(3- hydroxypropyl)amine oxide, dimethylhexadecylamine oxide.
  • Non-ionic surfactants that are long chain tertiary phosphine oxides, which include, for example, dodecyldimethylphosphine oxide, tetradecyldimethylphosphine oxide, tetradecylmethylethylphosphine oxide, 3,6,9,-trioxaoctadecyldimethylphosphine oxide, cetyldimethylphosphine oxide, 3-dodecoxy-2-hydroxypropyldi(2-hydroxyethyl) phosphine oxide, stearyldimethylphosphine oxide, cetylethylpropylphosphine oxide, oleyldiethylphosphine oxide, dodecyldiethylphosphine oxide, tetradecyldiethylphosphine oxide, dodecyldipropylphosphine oxide, dodecyldi(hydroxymethyl)phosphine oxide, dode
  • Non-ionic surfactants that are long chain dialkyl sulfoxides containing one short chain alkyl or hydroxy alkyl radical of to about 3 carbon atoms (usually methyl) and one long hydrophobic chain which contain alkyl, alkenyl, hydroxy alkyl, or keto alkyl radicals containing from about 8 to about 20 carbon atoms, from 0 to about 10 ethylene oxide moieties and from 0 to 1 glyceryl moiety.
  • Some examples include octadecyl methyl sulfoxide, 2-ketotridecyl methyl sulfoxide, 3,6,9,-trixaoctadecyl 2-hydroxyethyl sulfoxide, dodecyl methyl sulfoxide, oleyl 3-hydroxypropyl sulfoxide, tetradecyl methyl sulfoxide, 3-methoxytridecyl methyl sulfoxide, 3-hydroxytridecyl methyl sulfoxide, 3- hydroxy-4-dodecoxybutyl methyl sulfoxide.
  • Cationic surfactants useful in the formulations of the present invention contain amino or quaternary ammonium hydrophilic moieties which are positively charged when dissolved in the aqueous composition of the present invention.
  • Cationic surfactant vehicle materials among those useful herein are disclosed in the following documents, all incorporated by reference herein: M.C. Publishing Co., McCutcheon's Detergents & Emulsif ⁇ ers, (North American edition 1979); Schwartz, et al, Surface Active Agents, Their Chemistry and Technology, New York: Interscience Publishers, 1949; U.S. Patent No. 3,155,591; U.S. Patent No. 3,929,678; U.S. Patent No. 3,959,461; and U.S. Patent No. 4,387,090.
  • the cationic surfactant is present at from about 0.05 weight percents to about 5 weight percents.
  • Quaternary ammonium-containing cationic surfactant materials and salts thereof useful herein include dialkyldimethylammonium chlorides, wherein in the alkyl groups have from 12 to 22 carbon atoms and are derived from long-chain fatty acids, such as hydrogenated tallow fatty acid (Tallow fatty acids give rise to quaternary compounds wherein R 1 and R 2 have predominately from 16 to 18 carbon atoms), ditallowdimethyl ammonium chloride, ditallowdimethyl ammonium methyl sulfate, dihexadecyl dimethyl ammonium chloride, di(hydrogenated tallow) dimethyl ammonium chloride, dioctadecyl dimethyl ammonium chloride, dieicosyl dimethyl ammonium chloride, didocosyl dimethyl ammonium chloride, di(hydrogenated tallow) dimethyl ammonium acetate, dihexadecyl dimethyl ammonium chloride, dihexadecy
  • Ditallow dimethyl ammonium chloride, dicetyl dimethyl ammonium chloride, stearyl dimethyl benzyl ammonium chloride and cetyl trimethyl ammonium chloride are more useful in some embodiments of the present invention as quaternary ammonium salts, while in other embodiments it is di-(hydrogenated tallow) dimethyl ammonium chloride.
  • Salts of primary, secondary and tertiary fatty amines are also useful cationic surfactant vehicle materials in the context of the present invention.
  • the alkyl groups of such amines preferably have from 12 to 22 carbon atoms, and may be substituted or unsubstituted.
  • Secondary and tertiary amines are also useful, and more so tertiary amines.
  • Such amines useful herein, include stearamido propyl dimethyl amine, diethyl amino ethyl stearamide, dimethyl stearamine, dimethyl soyamine, soyamine, myristyl amine, tridecyl amine, ethyl stearylamine, N-tallowpropane diamine, ethoxylated stearylamine, dihydroxy ethyl stearylamine, and arachidylbehenylamine.
  • Suitable amine salts include the halogen, acetate, phosphate, nitrate, citrate, lactate and alkyl sulfate salts.
  • Such salts include stearylamine hydrochloride, soyamine chloride, stearylamine formate and N-tallowpropane diamine dichloride and stearamidopropyl dimethylamine citrate.
  • Cationic amine surfactants included among those useful in the present invention are disclosed in U.S. Patent No. 4,275,055, which is incorporated by reference herein.
  • Zwitterionic surfactants useful in many hair care formulations according to embodiments of the present invention, such as shampoos and conditioners, can be exemplified by those which can be broadly described as derivatives of aliphatic quaternary ammonium, phosphonium, and sulfonium compounds, in which the aliphatic radicals can be straight chain or branched, and wherein one of the aliphatic substituents contains from about 8 to 18 carbon atoms and one contains an anionic water- solubilizing group, e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate.
  • anionic water- solubilizing group e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate.
  • zwitterionic surfactants include, 4-(N,N-di(2-hydroxyethyl)-N- octadecylammonio)-butane-l-carbo xylate; 5-(S-3-hydroxypropyl-S- hexadecylsulfonio)-3-hydroxypentane-l -sulfate; 3-(P,P-diethyl-P-3,6,9- trioxatetradexocylphosphonio)-2-hydro xypropane-1-pho sphate; 3-(N,N-dipropyl-N-3- dodecoxy-2-hydroxypropylammonio)-propane - lphosphonate ; 3 -(N,N-dimethyl-N- hexadecylammonio)propane-l-sulfonate; 3-(N,N-dimethyl-N-hexadecylammonio)prop
  • betaines are also useful in the present invention.
  • betaines useful herein include the high alkyl betaines such as coco dimethyl carboxymethyl betaine, lauryl dimethyl carboxymethyl betaine, lauryl dimethyl alpha-carboxy-ethyl betaine, cetyl dimethyl carboxymethyl betaine, lauryl bis- (2-hydroxy-ethyl) carboxymethyl betaine, stearyl bis-(2-hydroxy-propyl) carboxymethyl betaine, oleyl dimethyl gamma-carboxypropyl betaine, lauryl bis-(2- hydroxypropyl)alphacarboxyethyl betaine, etc.
  • the sulfobetaines may be represented by coco dimethyl sulfopropyl betaine, stearyl dimethyl sulfopropyl betaine, lauryl dimethyl sulfoethyl betaine, lauryl bis-(2-hydroxy-ethyl) sulfopropyl betaine and the like; amido betaines and amidosulfobetaines, wherein the RCONH(CH 2 ) 3 radical is attached to the nitrogen atom of the betaine are also useful in this invention.
  • the amido betaines are more useful in some embodiments of the present invention.
  • amphoteric surfactants which can be used in the formulations according to embodiments of the present invention, are those which can be broadly described as derivatives of aliphatic secondary and tertiary amines in which the aliphatic radical can be straight chain or branched and wherein one of the aliphatic substituents contains from about 8 to about 18 carbon atoms and one contains an anionic water solubilizing group, e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate.
  • an anionic water solubilizing group e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate.
  • Examples of compounds falling within this definition are sodium 3- dodecyl-aminopropionate, sodium 3-dodecylaminopropane sulfonate, N-alkyltaurines such as the one prepared by reacting dodecylamine with sodium isethionate according to the teaching of U.S. Patent No. 2,658,072, N-higher alkyl aspartic acids such as those produced according to the teaching of U.S. Patent No. 2,438,091, and the products sold under the trade name "Miranol" and described in U.S. Patent No. 2,528,378.
  • surfactants can be used either alone or in combination in the hair care formulations according to some embodiment of the present invention.
  • surfactants such as alkyl sulfates, ethoxylated alkyl sulfates and mixtures thereof are utilized.
  • the hair care formulations are conditioner formulations and more so hair gel formulations
  • some optional embodiments include gel vehicle materials.
  • the vehicle comprises two essential components: a lipid vehicle material and a cationic surfactant vehicle material.
  • Such gel-type vehicles are generally described in the following documents, all incorporated by reference herein: Barry, "The Self Bodying Action of the Mixed Emulsifier Sodium Dodecyl Sulfate/Cetyl Alcohol", 28 J.
  • the vehicles may incorporate one or more lipid materials, referred to herein as comprising a "lipid vehicle material", singly or in combination, which are essentially water-insoluble, and contain hydrophobic and hydrophilic moieties.
  • lipid vehicle materials include naturally or synthetically-derived acids, acid derivatives, alcohols, esters, ethers, ketones, and amides with carbon chains of from 12 to 22, or from 16 to 18, carbon atoms in length. Fatty alcohols and fatty esters are particularly useful, and more so fatty alcohols.
  • Lipid vehicle materials among those useful herein are disclosed in Bailey's Industrial Oil and Fat Products, (3rd edition, D. Swern, ed. 1979), which is incorporated by reference herein.
  • Fatty alcohols included among those useful herein are disclosed in the following documents, all incorporated by reference herein: U.S. Patent No. 3,155,591; U.S. Patent No. 4,165,369; U.S. Patent No. 4,269,824; British Specification No. 1,532,585; and Fukushima et al, "The Effect of Cetostearyl Alcohol in Cosmetic Emulsions", 98, Cosmetics & Toiletries, 89-112 (1983).
  • Fatty esters included among those useful herein are disclosed in U.S. Patent No. 3,341,465, which is also incorporated by reference herein. If included in any of the formulations according to some embodiments of the present invention, the lipid vehicle material is present at from about 0.1 weight percents to about 10.0 weight percents.
  • Exemplary esters for use herein include cetyl palmitate and glycerylmonostearate.
  • Cetyl alcohol and stearyl alcohol are highly useful alcohols.
  • a particularly useful lipid vehicle material comprises a mixture of cetyl alcohol and stearyl alcohol containing from about 55 weight percents to about 65 weight percents of cetyl alcohol.
  • Tonics, gels and non-aerosol hairsprays utilize a solvent such as water or alcohol while mousses and aerosol hairsprays additionally utilize a propellant such as trichlorofluoromethane, dichlorodifluoromethane, dichlorotetrafluoroethane, monochlorodifluoromethane, trichlorotrifluoroethane, dimethylether, propane, n-butane and isobutane, used singly or admixed in various combinations, in addition to the liquid ovicidal/pediculicidal composition.
  • a propellant such as trichlorofluoromethane, dichlorodifluoromethane, dichlorotetrafluoroethane, monochlorodifluoromethane, trichlorotrifluoroethane, dimethylether, propane, n-butane and isobutane, used singly or admixed in various
  • the level of propellant can be adjusted as desired but is generally from about 3 weight percents to about 30 weight percents of the mousse composition and from about 15 weight percents to about 50 weight percents of the aerosol hairspray composition.
  • a tonic or hairspray product having a low viscosity preferably requires an emulsifying agent to keep the film-forming carbohydrate and the oil homogeneously dispersed in solution.
  • suitable emulsifying agents include nonionic, cationic, and anionic surfactants. Examples of such materials are described supra.
  • Co-surfactant systems are utilized in some of the formulations presented herein. For example, combinations of anionic and nonionic surfactants or cationic and nonionic surfactants. Generally, combinations of anionic and cationic surfactants will not provide the appropriate emulsifying benefits. If such an emulsifying agent is present, it is generally present at a level of from about 0.25 weight percents to about 7.5 weight percents of the formulation.
  • the specific surfactant materials or combinations of surfactant materials to be used and the particular levels of use are determined by those that will allow the formation of microemulsions or microsuspensions of the film- forming carbohydrate and the oil in the formulation.
  • a non-limiting example of such a surfactant emulsifier system is the combination of lauramine oxide and cocamide DEA.
  • Hairspray formulations according to embodiments of the invention are particularly challenging to formulate because the film-forming carbohydrate may not be soluble in typical hairspray solvents, such as ethanol. Hence, the film-forming carbohydrate may tend to precipitate out of solution over time and form a solid mass at the bottom of the container. This solid mass is un-redispersible in the solvent upon agitation.
  • Use of the above described surfactant emulsifying agents provides one solution to this problem.
  • Formulations as described herein in the form of a hairspray may comprise a volatile carrier system.
  • This may comprise any of those conventionally used in resin hairspray formulations, preferably a C 1-6 alkanols, such as ethanol.
  • This component "carries" the film-forming carbohydrate and the oil to the hair and than volatilizes, leaving the ovicidal/pediculicidal composition behind on the hair to provide eradicating activity against ectoparasites, as well as hairstyling hold.
  • the carrier is present in the hairspray formulation at from about 20 weight percents to about 90 weight percents, or from about 35 weight percents to about 90 weight percents of the formulation. Water can also be used to substitute for part of the volatile carrier component.
  • Hairspray compositions according to some embodiments of the invention may comprise from about 20 weight percents to about 40 weight percents of the presently disclosed liquid ovicidal/pediculicidal composition having a viscosity of from about 1,000,000 centistoke to about 20,000,000 centistoke; and a volatile carrier.
  • An additional component that is widely used in the hairspray formulations and in some embodiments of the present invention, is a hair setting polymer, also known as hair hold resins. Any polymer soluble or dispersible in the volatile carrier or solvent phase may be used. Solubility/dispersibility is determined at ambient conditions (e.g., temperature about 25° C. and atmospheric pressure). Suitable types of polymers include anionic, nonionic, amphoteric and cationic.
  • polymers include polyvinylpyrrolidone (PVP), copolymers of (PVP) and methylmethacrylate, copolymers of PVP and vinylacetate (VA), polyvinyl alcohol (PVA), copolymers of PVA and crotonic acid, copolymers of PVA and maleic anhydride, hydroxypropyl cellulose, hydroxypropyl guar gum, sodium polystyrene sulfonate,
  • PVP/ethylmethacrylate/methacrylic acid terpolymer vinyl acetate/crotonic acid/vinyl neodecanoate copolymer, octylacrylamide/acrylates copolymer, monoethyl ester of poly(methyl vinyl ether maleic acid), and octylacrylamide/acrylate/butylaminoethyl methacrylate copolymers.
  • PVP and PVP copolymers with other monomers may also be used, as well as any mixtures thereof.
  • These polymers are used at a level of from about 0.25 weight percents to about 20 weight percents, or from about 1 weight percents to about 20 weight percents of the total formulation.
  • the mass average molecular weight of the polymer is not critical, but is generally in the range of from about 2,000 to about 2,000,000.
  • Suitable neutralizing agents include 2-amino-2-methyl -1,3-propanediol (AMPD); 2- amino-2-ethyl-l,3 propanediol (AEPD); 2-amino-2-methyl-l-propanol (AMP); 2- amino-1-butanol (AB); monoethanolamine (MEA); diethanolamine (DEA); triethanolamine (TEA); monoisopropanolamine (MIPA); diisopropanol amine (DIPA); triisopropanolamine (TIPA); and dimethyl stearamine (DMS).
  • AMPD 2-amino-2-methyl -1,3-propanediol
  • AEPD 2- amino-2-ethyl-l,3 propanediol
  • AMP 2-amino-2-methyl-l-propanol
  • 2- amino-1-butanol (AB) monoethanolamine (MEA); diethanolamine (DEA); triethanolamine (TEA); monoisopropanolamine (MIPA
  • the hair care formulations described herein can contain a variety of other optional components suitable for rendering such compositions more acceptable.
  • Such conventional optional ingredients are well known to those skilled in the art, e.g., fragrances; deodorant agents; pearlescent aids such as ethylene glycol distearate; preservatives such as benzyl alcohol, methyl paraben, propyl paraben and imidazolidinyl urea; thickeners and viscosity modifiers such as a diethanolamide of a long chain fatty acid (e.g., PEG 3 lauric diethanolamide), cocomonoethanol amide, dimethicone copolyols, guar gum and derivatives thereof, methyl cellulose, starches and derivatives thereof; fatty alcohols such as cetearyl alcohol; sodium chloride; sodium sulfate; polyvinyl alcohol; ethyl alcohol; pH adjusting agents such as citric acid, sodium citrate, succinic acid, phosphoric acid, sodium hydroxide, sodium
  • Such optional ingredients generally are used individually at a level of from about 0.01 weight percents to about 10.0 weight percents, or from about 0.05 weight percents to about 5.0 weight percents of the formulation.
  • the content of the film-forming carbohydrate and the content of the oil in any of the hair care formulations according to embodiments of the invention can be calculated from the contents thereof in the ovicidal/pediculicidal composition presented herein, and the content of that ovicidal/pediculicidal composition in the given hair care formulation.
  • the content of the film-forming carbohydrate is 20 weight percents in the ovicidal/pediculicidal composition, and the content of the oil is 2 weight percents in the ovicidal/pediculicidal composition, and the content of the ovicidal/pediculicidal composition in the hair care formulation is 50 weight percents
  • the content of the film-forming carbohydrate is 10 weight percents in the hair care formulation
  • the content of the oil is 1 weight percents in the hair care formulation.
  • the respective level of the film-forming carbohydrate incorporated therein is from about 10 weight percents to about 30 weight percents and the level of the oil is from about 1 weight percents to about 5 weight percents.
  • the respective level of the film-forming carbohydrate incorporated therein is from about 10 weight percents to about 30 weight percents and the level of the oil is from about 2 weight percents to about 10 weight percents.
  • the respective level of the film-forming carbohydrate incorporated therein is from about 10 weight percents to about 30 weight percents and the level of the oil is from about 5 weight percents to about 15 weight percents.
  • the pH of the formulations described herein is between about 3 and about 8, or between about 5 and about 8, as typically maintained for hair care products known in the art.
  • compositions and /or formulations described herein do not contain components which unduly interfere with the desired performance and physical and physicochemical characteristics of the hair care formulations.
  • any of the hair care formulations described herein is packaged in a packaging material and is identified in print, in or on the packaging material, for use in eradicating insect ectoparasites in general, and human head lice in particular.
  • the ovicidal/pediculicidal composition and a formulation of a standard hair care product may be packaged separately.
  • the user adds the ovicidal/pediculicidal composition into the standard hair care product and uses the resulting formulation as indicated.
  • the user is instructed to shake (e.g., by vigorous shaking) the combined formulation.
  • a process for preparing the hair care formulations presented herein which include mixing the film-forming carbohydrate, the oil and the water until a homogeneous liquid ovicidal/pediculicidal composition is obtained; and adding this liquid ovicidal/pediculicidal composition into a precursor formulation of a hair care formulation, so as to amount to a relative content from about 10 or 20 weight percents to about 60 weight percents of the total weight of the finished hair care formulation.
  • the hair care formulations described herein can be made using any conventional formulations and mixing techniques.
  • the film-forming carbohydrate aqueous solution and the oil are combined with the other hair care formulation components in such a fashion so as to obtain a stable emulsion.
  • a stable emulation can be afforded, for example, by the addition of an effective amount of an emulsifier and a suitable mechanic mixing technique which is capable of a vigorous agitation of the formulation so as to arrive at a stable emulsion thereof
  • the relative amount of each of the ingredients, other than the film-forming carbohydrate and the optional oil, is determined according to the type of hair care product afforded by the formulation, which can be selected from the group consisting of a shampoo, a conditioner, a mask, a mousse, a gel, a hair spray, a lotion, a moisturizer, a tonic and a serum, and the rest of the ingredients present in the formulations are selected suitable per the particular intended product.
  • the hair care formulations of the present invention can be used in conventional ways to provide the hair conditioning/styling/holding as other hair care products in the market. Such ways of use depends upon the type of formulation/product employed, and generally involves application of an effective amount of the formulation to the hair, which may then be rinsed from the hair (as in the case of shampoos and some conditioning products) or allowed to remain on the hair (as in the case of spray, mousse, gel, and tonic products).
  • the present formulations are provided as a measure against ectoparasites, the effective amount and mode of use are regarded as part of the anti- phthirapteral treatment.
  • the formulation is applied to wet or damp hair prior to combing, drying and styling of the hair. Use of the formulations described herein in this manner provides optimal eradication of the ectoparasite in the hair. After the formulation is applied to the hair, it is maintained in the hair for a time period that ranges from 10 seconds to 10 minutes, the hair is then combed with a dense comb, dried and styled in the usual ways of the user.
  • a method of eradicating a population of at least one ectoparasite in human hair as defined herein, which is effected by:
  • the pre-determined time period ranges from 10 seconds minute to 20 minutes, from 10 seconds minute to 10 minutes, from 10 seconds to 5 minutes, from 10 seconds to 3 minutes, from 10 seconds to 2 minutes, from 10 seconds to one minute, from 30 seconds to 1 minute, or from 1 minute to 6 minutes, from 2 minutes to 6 minutes, from 3 minutes to 6 minutes, or from 4 minutes to 6 minutes.
  • the ovicidal/pediculicidal effective amount is as defined herein for "effective amount", and can be determined by a person skilled in the art based on the hair area to be treated, the concentration of the active ingredient(s) in the formulation, the age of the subject being treated, the level of infestation, and other parameters. In some embodiments, the effective amount ranges from 10 grams to 30 grams of the hair care formulation.
  • the method is also effected by, subsequent to the application of the formulation, working the formulation through the hair and scalp.
  • the anti-ectoparasite ingredient namely the liquid ovicidal/pediculicidal composition presented herein, may also be used directly on the hair as a hair care formulation perse.
  • the use of the hair care formulations presented herein should be followed by mechanical removal of the dead or dislocated individual insects from the hair. Such a act is effectively afforded and effected by use of a dense comb, typically known as a "lice comb". This act will remove the part of the population of ectoparasites, the hair grip thereof was loosened by the combination of film-forming carbohydrate and the oil. Hence, in some embodiments, the method is further effected by combing the hair with a dense comb, subsequent to washing the formulation.
  • any of the formulations and compositions for the eradication of ectoparasites described herein can be supplemented with at least one other anti-phthiraptera agent known in the art, such as organochlorines
  • organophosphates for example, malathion
  • compositions and formulations described herein can be utilized in combination with hair combing, using a particularly designed lice comb, as mentioned hereinabove, and/or in combination with any other device, such as, for example, devices that blow hot air.
  • the application of the presently disclosed hair care formulations should be repeated at least twice in cases where the ectoparasite infestation is severe or lasts long enough to allow the laying of ova (eggs) in the infested hair.
  • the repeated application of the formulations will ensure that the newly hatched nymphs will not grow and mature so as to erect another generation.
  • hair care formulations presented herein should be repeated after each case of re-infestation by contact with an external source of parasites, particularly in cases where the treated subject comes in social contact with other subjects suspected of being infested with the ectoparasite.
  • any of the formulations, compositions and methods described herein can be utilized also for preventing lice infestation in cases where such infestation is likely to occur, as long as the formulations and/or compositions are applied regularly, as long as exposure to infestation is optional.
  • compositions and methods according to some embodiments presented herein are not limited to the treatment of lice and lice eggs, rather the compositions and methods can be useful in treating other parasites and pests.
  • Insecticide-based anti-lice formulations are typically tested by a lice killing rate standard. This standard, however, fails to address the recurrence of the infestation of the subject's hair by lice, which is one of the main symptoms that accompany lice infestation.
  • the efficacy of the formulations presented herein is determined by the lack of reoccurrence of the infestation of the subject's hair by lice.
  • a shampoo product was prepared and applied on more than 50 lice-infested children of both sexes, ages ranging from 4-14, living in normal conditions including social interactions in daycare and schools facilities as well as homes with other family members.
  • Shampoo formulation utilized glucose syrup 80/42 (Gal'am Industries Ltd., Israel, Cat No. GLl 160100) as a film-forming carbohydrate, and canola oil and tocopheryl acetate as oil.
  • the formulation is presented in Table 2 below.
  • the hair care formulations of the present embodiments can be made using any conventional formulations and mixing techniques. However, it is noted that in some embodiments it is best to form a stable emulsion from the film-forming carbohydrate aqueous solution and the oil prior to combination with the other hair care composition components.
  • a volatile carrier is used in the formulations described herein to lower the viscosity of liquid ovicidal/pediculicidal composition, it may be combined with the liquid ovicidal/pediculicidal composition in several steps. Mixing the volatile carrier and the liquid ovicidal/pediculicidal composition together this way avoids disruption of the homogeneous emulsion of the liquid ovicidal/pediculicidal composition.
  • a resin is also used in the formulation, it may be mixed with the volatile carrier prior to combination of the carrier material with the liquid ovicidal/pediculicidal composition. The resulting mixture can then be formulated into a variety of hair care products including tonics, shampoos, conditioners, mousses, gels and hair sprays. It is noted that the pH of the final formulation is adjusted, if necessary, to be between 3 and 7, preferably between 6 and 7.
  • Glucose syrup (DE 43) as a film-forming carbohydrate - 40 weight percents
  • Deionized water - 70 weight percents (QS, Quantum Sufficiat to complete to 100 weight percents).
  • QS Quantum Sufficiat to complete to 100 weight percents.
  • a mixer such as a ribbon type blender, the components of the liquid ovicidal/pediculicidal composition premix are combined and mixed until a homogeneous emulsion is formed.
  • the shampoo processing is effected as follows: ammonium lauryl sulfate, citric acid, sodium citrate and sodium hydroxide are added to the distilled water at about 15° C. The mixture is heated to from 70° C to 80° C. The cocamide MEA and glycol distearate are added at this point. The ammonium laureth-3 sulfate, cetearyl alcohol and the ovicidal/pediculicidal composition premix are blended at 70° C to 90° C. This mixture is added to the batch following the glycol distearate. The preservative and fragrance are added thereafter. The batch is mixed for 5 minutes and then cooled to room temperature (15° C to 25° C). Sodium chloride and ammonium xylene sulfonate are added for viscosity control as needed. The final compositions have a pH of from about 5.0 to about 6.0.
  • compositions are used in the same way one would use a standard shampoo, all but keeping the shampoo on the hair for 4-10 minutes. The hair is then combed with a dense comb, dried and styled in the usual way.
  • the conditioner processing is effected as follows: hydroxyethyl cellulose is added to the distilled water at a temperature of 15° C to 40° C. This mixture is well- dispersed, then heated to a temperature of from 60° C to 90° C. Ingredients 2 through 8 are added to the batch while the temperature is maintained in this range. The mixture is stirred for approximately 10 minutes, then cooled to approximately 50° C. The remaining ingredients and the ovicidal/pediculicidal composition premix are added at this temperature, then cooled to room temperature. The finished compositions have a pH of from about 3.5 to about 4.5.
  • conditioner formulations are used as one would use standard rinse-type conditioning products, i.e., after shampooing, the conditioner is applied to the hair, allowed to stay on the hair for at least 4-10 minutes, and then rinsed from the hair. The hair is then combed with a dense comb, dried and styled in the usual way.
  • a non-aerosol hair tonic spray product is prepared as follows.
  • the lauramide oxide is mixed with part of the water at a ratio of 4 to 1 with, for example, a ribbon type mixer until homogeneous.
  • the cocamide DEA is added and mixed until homogeneous.
  • the ovicidal/pediculicidal composition premix prepared as presented hereinabove is added and mixed until homogeneous.
  • the remainder of the water is put into a stainless steel mixing vessel.
  • the Carbomer 956 is mixed into the water using, for example, a triblender or eductor mixer.
  • the premix is added while mixing until homogeneous.
  • the PVP/VA is then added and mixing is continued until the batch is homogeneous.
  • the preservative is added and mixing is continued until homogeneous.
  • the perfume is added and mixing is continued for an additional 10 minutes. Once the batch is well-mixed homogenization of the batch is performed using conventional apparatus.
  • the final product is an opaque liquid having a pH of about 6 and 7.
  • This exemplary hair tonic is sprayed onto damp hair and the hair is then combed, styled and dried.
  • the amount of tonic used will depend on the volume/hold benefits desired and the amount of hair being treated as well as the texture of the hair.
  • the exemplary aerosol mousse are prepared by combining all ingredients except the aerosol propellant into a batch called the concentrate.
  • This concentrate is made by combining with agitation all of the ingredients except for the preservative and the premix prepared as described hereinabove, and mixing continued until these are thoroughly dispersed.
  • the resulting mixture is then homogenized using conventional apparatus.
  • the resulting concentrate has a pH of from 6 to 7.
  • Aerosol mousse cans are prepared by placing 135 grams of concentrate into 5 ounce aluminum epoxy lined cans, placing mousse valves on can tops, drawing a vacuum to evacuate can headspace (to remove air), and crimping the valves into place.
  • the propellant (15 grams) is added by pressure filling through the valve stem.
  • the gel formulations according to some embodiments of the present invention are prepared using the method outlined in the example for the hair tonic, except that the
  • Carbomer 940 is substituted for the Carbomer 956 and the triethanolamine is added before the preservative and mixed in until homogeneous. These compositions have a pH of about 6 to 7.
  • Ovicidal/pediculicidal composition premix (see, Example 3) - 20 weight percents; PVP/VA copolymer (50/50) - 10 weight percents;
  • the Tixogel® is added to the ovicidal/pediculicidal composition premix and mixed until homogeneous, and the ethanol is thereafter added and mixed until homogeneous. Using conventional mixing the PVP/VA/copolymer is added. The octyl salicylate, keratin amino acids, and fragrance are mixed into the composition in that order.
  • EXAMPLE 10 Clinical Studies The efficacy of a hair care formulation as described, for example, in Example 1 hereinabove, is tested in a double blind placebo control trial.
  • Treatment includes a daily hair wash, effected by applying the formulation to wet hair, rubbing the hair and scalp, maintaining the formulation on the hair and scalp for 3 minutes and rinsing the formulation in water.
  • Hair washing is followed by combing the hair during 5 minutes with a dense comb.
  • Treatment is continued for 10 days, under daily supervision.
  • Group II which previously was treated without the composition, is not treated with a formulation as described herein, while Group I, previously treated with the composition, is now treated with the placebo.
  • the same protocol as described hereinabove is applied, and same documentation is performed.
  • results are analyzed for determining a statistically significant improved effect of the tested formulation, as compared with the placebo.

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